A tracheostomy is a surgical procedure performed on a patient when there is a blockage in the natural airways of a patient's throat, which blockage causes difficulty in breathing. An incision is made in the patient's throat, and a tracheostomy tube or cannula is inserted through the incision into the trachea. The procedure allows air to bypass the nose and throat and pass into the trachea in the respiratory process.
Tracheostomy tubes are well-known in the art, especially for adult patients. For example, U.S. Pat. No. 4,235,229 to Ranford et al. is directed to an adjustable tracheostomy tube assembly, which includes three prominent features: the tracheostomy tube, a neck collar, and a tube extension. The tracheostomy tube includes a ridged section at the proximal end, i.e., the patient's neck end. The collar includes a sleeve portion, which has lugs or tabs designed to interact with the ridges in the tracheal tube. In this manner, the tracheostomy tube can be manipulated back and forth through the sleeve portion to lengthen or shorten the tube in the trachea as required for the individual patient. The lugs connect the tube in position.
Some prior art disclosures relating to tracheostomy tubes suggest pediatric use. For example, U.S. Pat. No. 4,909,248 to McLennan-Anderson is directed to a tracheostomy tube assembly specifically meant for pediatric use. The tracheostomy tube assembly is designed to eliminate the risk of the tube becoming blocked at the patient's neck by folds of skin contacting the open end of the tube. U.S. Pat. No. 5,054,482 to Bales is directed to a tracheostomy tube assembly, described as being useful for neonates and infants. The assembly includes a tracheostomy tube connected to a base that matches the contour of the patient's neck. U.S. Pat. No. 3,499,450 to Rathjen is also directed to a pediatric-sized tracheostomy tube. The tube is manufactured to any suitable length and then cut to a desired length before insertion. The excess is then discarded. Thus, the tracheostomy tube is stocked in only one length.
One of the difficulties normally associated with performing a tracheostomy on an infant, adolescent, or smaller-sized patient (referred to hereinafter as a "child") is that the child does not have a fully developed neck. Because of this, a tracheostomy procedure normally associated with an adult cannot be efficiently conducted on a child. Further, because most tracheostomy tubes now used on adolescent children are essentially down-sized or manipulated versions of adult tracheostomy tube assemblies, they are ill-fitting and must be continually replaced. Additionally, the tracheostomy tubes are not adequately adapted to the angle of the trachea and the short necks of children. The importance of a well-fitting device, particularly in situations were apprehensive parents must tend to infants wearing the tracheostomy tube assembly, cannot be over-emphasized.
While tracheostomy tube assemblies are available for use in children, and specifically for pediatric use, there is no known adjustable tracheostomy tube assembly specifically designed to adapt to the specific needs of children and to allow for the improved care of the tracheostomy site.